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Details for New Drug Application (NDA): 075417

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NDA 075417 describes CLOZAPINE, which is a drug marketed by Mayne Pharma, Barr Labs Inc, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Mylan, Mylan Pharms Inc, Teva Pharms Usa, Sandoz, Par Pharm, and Accord Hlthcare, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 075417

Tradename:
CLOZAPINE
Applicant:
Mylan
Ingredient:
clozapine
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075417

Suppliers and Packaging for NDA: 075417

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE
clozapine
TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0825 0378-0825-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0825-01)
CLOZAPINE
clozapine
TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0860 0378-0860-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 27, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 27, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Apr 15, 2010TE:ABRLD:No


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